National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2014 (No. 2) - PB 11 of 2014

Overview

The National Health Act 1953, enacted by the Australian Parliament, establishes the legal framework for the provision of health services and the administration of health-related policies across Australia. One of its provisions, specifically under subsection 100, allows the Minister to create special arrangements for the supply of pharmaceutical benefits, thereby enabling the adaptation of these arrangements to meet specific healthcare needs. The National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2014 (No. 2) was introduced to address the need for updating the highly specialised drugs program for hospitals. This amendment was prompted by changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and seeks to align the Special Arrangement with these updates. The policy objective of this legislative instrument is to ensure that the highly specialised drugs program remains effective and responsive to the latest clinical and pharmaceutical developments, facilitating better access to essential treatments for patients with chronic conditions in hospital settings.

Scope and Application

The National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2014 (No. 2) amends the existing special arrangement made under the National Health Act 1953 to update the list of highly specialised drugs available for the treatment of chronic conditions that can only be administered in hospitals with appropriate specialised facilities. The Act applies to pharmaceutical benefits provided under the Special Arrangement, which includes both public and private hospitals, as well as pharmaceutical companies supplying these drugs. The amendment instrument specifically adds Nevipin, a brand of Nevirapine in the form of 200 mg oral tablets, to the list of approved drugs, with Actavis Pty Ltd designated as the responsible entity for this brand. This amendment reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and is effective from 1 March 2014. The legislative instrument is subject to consultation with the Pharmaceutical Benefits Advisory Committee, an independent body comprising experts from various healthcare fields, which ensures recommendations align with clinical effectiveness, safety, and cost-effectiveness criteria.

Key Provisions

The main operative sections of this legislation involve amendments to the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement 2010 (Section 100(1)). This special arrangement, which is set out in the National Health Act 1953, relates to the supply of pharmaceutical benefits, particularly highly specialised drugs for hospitals (Section 100(1)). The Act enables the Minister to make special arrangements for the supply of pharmaceutical benefits, and it also allows for these arrangements to be varied or revoked (Section 100(2)). The amendments introduced by this instrument reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, and they include the addition of a new brand, Nevipin, for the drug Nevirapine in the form of a 200 mg oral tablet (Section 100(3)). The responsible person for this new brand is Actavis Pty Ltd, whose ABN is 17 003 854 626, and the responsible person code for Actavis Pty Ltd has been updated accordingly. The obligations and requirements imposed by the Act on the parties and entities it governs include the need for consultation with relevant stakeholders, particularly through the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC is an independent expert body established under Section 100A of the Act to make recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. The PBAC includes members from various healthcare-related fields, such as consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists, and specialists. The PBAC process ensures that the recommendations made regarding the listing of medicines on the Pharmaceutical Benefits Scheme (PBS) take into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety, and cost-effectiveness compared with other treatments. Pharmaceutical companies are also consulted throughout the process of changes to the listings on the PBS and for this instrument, including agreement to final listing details. Any breaches of the provisions of the Act, including the failure to adhere to the special arrangements made for the supply of pharmaceutical benefits, may result in civil or criminal consequences. However, the specific offences, penalties, or consequences for breach are not detailed within the text of this legislation. It is important for parties and entities governed by the Act to ensure compliance with the requirements and obligations set out in the National Health Act 1953 and any associated special arrangements, such as the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement 2010, to avoid potential civil or criminal liability. The maximum penalties for breaches of the Act are not stated in this text, and further research into the relevant sections of the Act would be necessary to determine the specific penalties applicable to any breaches.